A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Failure

Question 1

Journal

Year

Answer 1

Journal: The New England Journal of Medicine 2005

Question 2

Aims

Answer 2

To assess efficacy, safety, and acceptability of misoprostol

Question 3

Study Design

Answer 3

RCT

Question 4

Participants

Answer 4

652 women with 1st-trimester pregnancy failure

Question 5

Inclusion Criteria

Answer 5

• Women who had anembryonic gestation or embryonic/fetal death with US
  o Embryonic pole or CRL 5-40mm without cardiac activity
  o Anembryonic gestational sac with MSD 16-45mm
  o Growth of gestational sac <2mm over 5/7, or <3mm over 7/7
  o Increase in hCG of <15% over 2/7 with yolk sac visualized
  o Incomplete or inevitable abortion
   Incomplete = passage of some POC with residual anteroposterior lining >30mm on TVUS and uterine size indicating <13/40
   Inevitable = IU gest sac <45mm or embryonic pole <40mm and internal cervical os open to digital examination with active PV bleeding

Question 6

Exclusion Criteria

Answer 6

• Anaemia = Hb <9.5
• Haemodynamic instability
• History of clotting disorder or using anticoagulants (not including aspirin)
• Allergic to PGs or NSAIDs
• Or previously undergone surgical or medical abortion that was either self-induced or induced by other physicians during current pregnancy

Question 7

Intervention

Answer 7

• Randomly assigned to receive 800mcg misoprostol PV or to undergo vacuum aspiration in 3:1 ratio
• Misoprostol: treatment on D1, 2nd dose on D3 if expulsion incomplete, vacuum aspiration on D8 if expulsion still incomplete
• Treatment failure = surgical treatment (for misorprostol group) or repeated aspiration (for vaccum-aspiration group) within 30 days after initial treatment

Question 8

Primary end-points

Answer 8

Treatment failure = surgical Tx (misoprostol group) or repeated aspiration (surgery group) within 30/7 of initial Tx

Question 9

Summary of results

Answer 9

• Misoprostol (491 women)
  o 71% complete expulsion by D3, 84% complete expulsion by D8
  o 78% would use again, 83% would recommend to others
• Treatment failure: misoprostol 16%, surgical 3%
• Haemorrhage or endometritis requiring hospitalization was rare (<1% in each group, no significant difference)

Question 10

Limitations

Answer 10

• Women who had anembryonic gestation or embryonic or fetal death overrepresented
• Only studied vaginal administration of misoprostol (Prev studies indicated efficacy is similar in PV or PO, but SEs higher in PO
• Unknown whether 800mcg misoprostol represents lowest effective dose

Question 11

Conclusion

Answer 11

• Treatment of early pregnancy failure with 800mcg of misoprostol vaginally is a safe and acceptable approach, with a success rate of ~84%